According to the Alliance for a Stronger FDA, the budget request is “in contrast to the steady investments over the past years in FDA’s critical public health work, including more than a $100 million increase in the prior fiscal year.”
Steven Grossman, the Alliance’s Deputy Executive Director, told us that the next step will be working closely with Congress in order to secure additional funding for the FDA.
“The request identifies a large number of needs,” he explained, “and it’s very inconsistent with the actual request in terms of dollars. The narrative and the dollars are inconsistent with each other.”
Additionally, it’s important to note that the budget is composed greatly of user fees. So, as Grossman explained, to say the budget is $2.743bn is comparable to winning the Powerball and listing the winnings as part of your assets.
“It’s a barren request,” said Grossman – and if additional funding isn’t allocated, “It will comprise FDA’s ability to be a partner in the innovation process.”
Grossman added that the FDA’s needs increase each year and because of this, funding should follow, specifically, to address legislation, increasing globalization, and mounting biosimilar applications – in fact, Dr. Woodcock addressed Congress earlier this week, commenting on the lack of resources to meet this demand.
“The more complex the science the more time it takes to review it properly,” explained Grossman.
Ultimately, with less money, the FDA will have to choose among competing public health priorities. “Increasing facility inspections (domestic and foreign) is one of those priorities and it is hard to predict what FDA will choose to do if more money isn’t appropriated,” added Grossman.
While the FDA may receive an additional $75m as part of the cancer “moonshot” initiative, this will require additional authorizing legislation as well as a budget “pay for.”
Troy Zimmerman, Alliance VP and VP for Government Relations at the National Kidney Foundation added: “This budget provides no investment in FDA’s core functions, even while additional funding is needed for food safety, precision medicine, drug compounding oversight, antibiotics development and other initiatives. The potential cancer funding increment would be welcome, but does not leave us any less concerned.”
PhRMA shows additional concern
The Pharmaceutical Research and Manufacturers of America (PhRMA) also released a statement following the budget’s announcement expressing similar concerns.
“The President’s budget goes in the opposite direction by including harmful and misguided proposals that would hurt patients and stifle innovation,” it said, citing mandatory public disclosure of proprietary information that “would undermine our competitive market-based system and incentives for innovation.”
According to the association, the budget also includes proposals that would slow new treatment development by reducing intellectual property incentives.
“We appreciate the President’s continued interest in personalized medicine and the commitment to a moonshot to cure cancer, but believe those goals will only be achieved with a public policy environment that supports continued medical innovation,” PhRMA said in its release.
“As our companies continue working to help patients live longer, healthier lives, we must ensure polices support access to high quality, patient-centered care and continue to encourage development of innovative, life-changing medicines.”